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Clinical Trials/NCT01228552
NCT01228552
Unknown
Phase 3

A Randomized Double Blind, Placebo Controlled Phase III Trial to Determine the Efficacy and Safety of Topical Intra-oral Ketoprofen for the Treatment of Acute Migraine

Behar, Caren, M.D.1 site in 1 country100 target enrollmentDecember 2011
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ConditionsMigraine DisordersMigraine HeadacheMigraineAcute Migraine
InterventionsTopical, intra-oral ketoprofen gelPlacebo gel
DrugsTopical, intra-oral ketoprofen gel

Overview

Phase
Phase 3
Intervention
Topical, intra-oral ketoprofen gel
Conditions
Migraine Disorders
Sponsor
Behar, Caren, M.D.
Enrollment
100
Locations
1
Primary Endpoint
Pain relief (defined as at least 2 graded reduction in a 5-grade scale) at 120 minutes post-treatment
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of intra-oral topical ketoprofen for the treatment of acute migraine.

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
January 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Behar, Caren, M.D.

Eligibility Criteria

Inclusion Criteria

  • •Established diagnosis of Migraine as per IHS with aura
  • •Established diagnosis of Migraine as per IHS without aura
  • •At least 2 migraines per month
  • •At least 18 years of age

Exclusion Criteria

  • •Pregnancy or Lactation
  • •Other Headache Conditions including basilar, hemiplegic, or ophthalmoplegic migraines
  • •Chronic Daily Headache
  • •Allergy or Sensitivity to NSAIDs
  • •Other Severe Medical Conditions including GI bleeding, blood dyscrasias, thrombocytopenia

Arms & Interventions

Topical, intra-oral ketoprofen gel

Intervention: Topical, intra-oral ketoprofen gel

Placebo gel

Intervention: Placebo gel

Outcomes

Primary Outcomes

Pain relief (defined as at least 2 graded reduction in a 5-grade scale) at 120 minutes post-treatment

Time Frame: Within 240 minutes post-treatment

Secondary Outcomes

  • Pain relief at 30, 60, and 240 minutes post-treatment based on headache severities reported in patient's journals(Within 240 minutes post-treatment)
  • Relief of Photophobia at 30, 60, 120, and 240 minutes post-treatment(Within 240 minutes post-treatment)
  • Pain free status at 30, 60, 120, and 240 minutes post-treatment based on headache severities reported in patient's journals(Within 240 minutes post-treatment)
  • Relief of Phonophobia at 30, 60, 120, and 240 minutes post-treatment(Within 240 minutes post-treatment)
  • Relief of Nausea at 30, 60, 120 and 240 minutes post-treatment(Within 240 minutes post-treatment)
  • Relief of Vomiting 30, 60, 120 and 240 minutes post-treatment(Within 240 minutes post-treatment)
  • Need for Rescue Medication between the time of dosing to 240 minutes(Within 240 minutes post-treatment)

Study Sites (1)

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